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PowerPoint Slideshow about 'Directive 2010' - talasi

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“Regulatory frameworks...should provide a sufficiently flexible approach to anticipate, promote and make provision for technical progress in science and welfare...The focus needs to be on what must be achieved and why, and less on how it is to be achieved...inflexible regulatory frameworks have the potential to delay progress with the 3Rs.”

2. An experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available.

3. ...In a choice between experiments, those which use the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to provide satisfactory results shall be selected...

4. All experiments shall be designed to avoid distress and unnecessary pain and suffering to the experimental animals...

Article 8...

1. All experiments shall be carried out under general or local anaesthesia.

2. Paragraph 1 above does not apply when:

(a) anaesthesia is judged to be more traumatic to the animal than the experiment itself;

(b) anaesthesia is incompatible with the object of the experiment. In such cases appropriate legislative and/or administrative measures shall be taken to ensure that no such experiment is carried out unnecessarily.

Anaesthesia should be used in the case of serious injuries which may cause severe pain.

3. If anaesthesia is not possible, analgesics or other appropriate methods should be used in order to ensure as far as possible that pain, suffering, distress or harm are limited and that in any event the animal is not subject to severe pain, distress or suffering.

4. Provided such action is compatible with the object of the experiment, an anaesthetized animal, which suffers considerable pain once anaesthesia has worn off, shall be treated in good time with pain-relieving means or, if this is not possible, shall be immediately killed by a humane method.

47.1 The Commission and the Member States shall contribute to the development and validation of alternative approaches which could provide the same or higher levels of information as those obtained in procedures using animals, but which do not involve the use of animals or use fewer animals or which entail less painful procedures, and they shall take such other steps as they consider appropriate to encourage research in this field.

47.2 Member States shall assist the Commission in identifying and nominating suitable specialised and qualified laboratories to carry out such validation studies.

Recital 10... the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so. To that end, it seeks to facilitate and promote the advancement of alternative approaches.

Recital 46... In order to increase competitiveness of research and industry in the Union and to replace, reduce and refine the use of animals in procedures, the Commission and the Member States should contribute through research and by other means to the development and validation of alternative approaches.

1. The Commission and Member States should encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals but which involve fewer animals or which entail less painful procedures, and shall take such other steps as they consider appropriate to encourage research in this field. The Commission and Member States shall monitor trends in experimental methods.

“...to improve the application of the 3Rs and promote research into alternatives, reducing the need for toxicity testing through better sharing of data, and encouraging the validation and acceptance of alternatives.“

4. Previously: National representation on the ECVAM Scientific Advisory Committee

Member States shall ensure that each breeder, supplier and user sets up an animal-welfare body.

2. ...include at least the person or persons responsible for the welfare and care of the animals and, in the case of a user, a scientific member...

3. Member States may allow small breeders, suppliers and users to fulfil the tasks laid down in Article 27(1) by other means.

Article 27 Tasks of the animal-welfare body

(a) advise..on matters related to the welfare of animals...acquisition, accommodation, care and use;

(b) advise...on the application of the requirement of replacement, reduction and refinement...informed of technical and scientific developments ...;

(c) establish and review internal operational processes ...;

(d) follow the development and outcome of projects...identify and advise as regards elements that further contribute to replacement, reduction and refinement; and

(e) advise on rehoming schemes...

Recital 31

Animal-welfare considerations should be given the highest priority in the context of animal keeping, breeding and use. Breeders, suppliers and users should therefore have an animal-welfare body in place with the primary task of focusing on giving advice on animal-welfare issues. The body should also follow the development and outcome of projects at establishment level, foster a climate of care and provide tools for the practical application and timely implementation of recent technical and scientific developments in relation to the principles of replacement, reduction and refinement, in order to enhance the life-time experience of the animals. The advice given by the animal-welfare body should be properly documented and open to scrutiny during inspections.

independent ethical advice to the certificate holder, particularly with respect to project licence applications, and standards of animal care and welfare;

to provide support to named persons and advice to licensees regarding animal welfare and ethical issues arising from their work; and

to promote the use of ethical analysis to increase awareness of animal welfare issues, and develop initiatives leading to the widest possible application of the 3Rs (replacement, reduction and refinement).

promoting the development and uptake of reduction, replacement and refinement alternatives in animal use, where they exist, and ensuring the availability of relevant sources of information;

examining proposed applications for new project licences and amendments to existing licences, with reference to the likely costs to the animals, the expected benefits of the work and how these considerations balance;

providing a forum for discussion of issues relating to the use of animals and considering how staff can be kept up to date with relevant ethical advice, best practice, and relevant legislation;

undertaking retrospective project reviews and continuing to apply the 3Rs to all projects, throughout their duration;

considering the care and accommodation standards applied to all animals in the establishment, including breeding stock, and the humane killing of protected animals;

regularly reviewing the establishment's managerial systems, procedures and protocols where these bear on the proper use of animals;

advising on how all staff involved with the animals can be appropriately trained and how competence can be ensured.

...ensure as wide an involvement of establishment staff as possible in a local framework acting to ensure that all use of animals in the establishment...considered and justified; that proper account is taken of...the 3Rs); and that high standards of accommodation and care are achieved.

...Veterinary Surgeon and representatives from among the Named Animal Care & Welfare Officers should be involved...project licensees and personal licensees should also be represented...Where possible, the views of those who do not have responsibilities under the Act should be taken into account. One or more lay persons, independent of the establishment, should also be considered.

Article 49 National committees for the protection of animals used for scientific purposes

1. Each Member State shall establish a national committee for the protection of animals used for scientific purposes. It shall advise the competent authorities and animal-welfare bodies on matters dealing with the acquisition, breeding, accommodation, care and use of animals in procedures and ensure sharing of best practice.

2. The national committees referred to in paragraph 1 shall exchange information on the operation of animal-welfare bodies and project evaluation and share best practice within the Union.

Recital 48

There is a need to ensure a coherent approach to project evaluation and review strategies at national level.

Member States should establish national committees for the protection of animals used for scientific purposes to give advice to the competent authorities and animal- welfare bodies in order to promote the principles of replacement, reduction and refinement.

A network of national committees should play a role in the exchange of best practice at the level of the Union.

1. Each Member State shall designate...competent authorities responsible for the implementation of this Directive...may designate bodies other than public authorities for the implementation of specific tasks laid down in this Directive only if there is proof that the body:

(a) has the expertise and infrastructure required to carry out the tasks; and

(b) is free of any conflict of interests as regards the performance of the tasks...

2. Each Member State shall communicate details of a national authority serving as contact point for the purposes of this Directive to the Commission by 10 February 2011, as well as any update to such data.

The Commission shall make publicly available the list of those contact points.

The current UK provision:-

A single Government Department (the Home Office) is the national competent authority.

1. The Commission and the Member States shall contribute to the development and validation of alternative approaches...take such other steps as they consider appropriate to encourage research in this field.

2. Member States shall assist the Commission in identifying and nominating suitable specialised and qualified laboratories to carry out such validation studies...

5. Member States shall nominate a single point of contact to provide advice on the regulatory relevance and suitability of alternative approaches proposed for validation.

Recital 46

In order to increase competitiveness of research and industry in the Union and to replace, reduce and refine the use of animals in procedures, the Commission and the Member States should contribute through research and by other means to the development and validation of alternative approaches.

Recital 47

...It is necessary for the Commission to cooperate with the Member States when setting priorities for validation studies. The Member States should assist the Commission in identifying and nominating suitable laboratories to carry out such validation studies...

Member States shall facilitate, where appropriate, the establishment of programmes for the sharing of organs and tissues of animals killed.

Recital 27

Animal tissue and organs are used for the development of in vitro methods. To promote the principle of reduction, Member States should, where appropriate, facilitate the establishment of programmes for sharing the organs and tissue of animals that are killed.

Each Member State shall accept data from other Member States that are generated by procedures recognised by the legislation of the Union, unless further procedures need to be carried out regarding that data for the protection of public health, safety or the environment.

Recital 42

To manage risks to human and animal health and the environment, the legislation of the Union provides that substances and products can be marketed only after appropriate safety and efficacy data have been submitted.

Some of those requirements can be fulfilled only by resorting to animal testing, hereinafter referred to as ‘regulatory testing’.

It is necessary to introduce specific measures in order to increase the use of alternative approaches and to eliminate unnecessary duplication of regulatory testing.

For that purpose Member States should recognise the validity of test data produced using test methods provided for under the legislation of the Union.

Risk-based inspection programme – what are the risks to be managed, and how effectively must they be managed? Can the existing UK inspection programme be resourced and justified? Is it compliant? No qualification/ training standards set for inspectors.

Commission oversight (Article 35) is of inspection side only. Who will do this, what training is required?

Should more use be made of financial penalties and fees? Might this distort the internal market?